Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial

Summary

This phase II trial tests leuprolide acetate alone versus in combination with 177Lu-PSMA-617, with or without abiraterone acetate and prednisone, for the treatment of hormone-sensitive prostate cancer has spread to a limited number of anatomic sites at the time of initial diagnosis (de novo low volume metastasis) or that has come back after a period of improvement (recurrent). Standard of care treatment for prostate cancer usually includes androgen deprivation therapy, with or without abiraterone acetate and prednisone. Leuprolide acetate is a form of androgen deprivation therapy. It blocks the body from making testosterone (a male hormone) and estradiol (a female hormone). It may stop the growth of prostate cancer cells that need testosterone to grow. 177Lu-PSMA-617 is a type of radioconjugate drug. Upon administration, vipivotide tetraxetan targets and binds to prostate specific membrane antigen (PSMA)-expressing tumor cells. Upon binding, PSMA-expressing tumor cells are destroyed by 177Lu through the specific delivery of radiation. PSMA, a tumor-associated antigen and type II transmembrane protein, is overexpressed on prostate tumor cells. Abiraterone acetate is a type of anti-androgen drug. It blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of cancer cells that need androgens to grow. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Giving 177Lu-PSMA-617 in combination with leuprolide acetate, with or without abiraterone acetate and prednisone, may be more effective at treating patients with recurrent or de novo low volume metastatic hormone-sensitive prostate cancer than giving leuprolide acetate alone.

Conditions

• Recurrent Prostate Adenocarcinoma
• Stage IVB Prostate Cancer AJCC v8
• Castration-Sensitive Prostate Cancer
• Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
• Prostate Cancer
• Prostate Adenocarcinoma
• Adenocarcinoma of the Prostate
• Localized Prostate Carcinoma
• Metastatic Prostate Cancer
• Metastatic Prostate Adenocarcinoma
• Advanced Prostate Cancer
• Advanced Prostate Adenocarcinoma

Interventions

DRUG

Abiraterone Acetate

Given PO

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

DRUG

Leuprolide Acetate

Given SC

DRUG

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

DRUG

Prednisone

Given PO

PROCEDURE

PSMA PET-CT Scan

Undergo PSMA PET/CT

OTHER

Quality-of-Life Assessment

Ancillary studies

PROCEDURE

Single Photon Emission Computed Tomography

Undergo SPECT

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Matthew K. Tollefson, MD · Mayo Clinic in Rochester

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2030-12-30

Completion

2030-12-30

FDA Drug

Yes

Countries

• United States

Study Locations